title: QUALZICE: a QUALitative exploration of the experiences of the participants from the ZICE clinical trial (metastatic breast cancer) receiving intravenous or oral bisphosphonates.
abstract: BACKGROUND
  This qualitative sub-study aimed to explore the experiences of participants on the National Cancer Research Institute ZICE clinical trial, a randomised trial assessing two types of bisphosphonate treatment in breast cancer patients with bone metastases. Participants in the clinical trial were randomly allocated to receive either zoledronate, delivered by an intravenous (IV) infusion at clinic, or oral ibandronate, taken at home.
  
  
  METHODS
  Qualitative research interviews were conducted with participant groups organised by treatment and location. Interviews covered experiences and understanding of bisphosphonate treatment, the experience of the delivery mechanisms (IV or oral), side effects and benefits, and quality of life issues. The analytic framework was interpretative phenomenological analysis.
  
  
  RESULTS
  This paper reports on one of four superordinate themes: participants' experience of the ZICE trial, which explores the participants' experiences with clinical trial-related processes. Results show that participants were generally satisfied with their randomised treatment, although most participants had an initial preference for oral bisphosphonates. Some difficulties were reported from participants for both interventions: needle phobia, poor veins, difficulty with swallowing and gastric side effects, but pain control was improved with both modes of delivery. However, the infused bisphosphonate was reported to lose effectiveness after three weeks for some participants, whereas the oral bisphosphonate was reported to give consistent pain control. Geographical location and distance to travel made little difference to convenience of access to clinic as the reported lengths of travel time were similar due to traffic congestion in the urban areas. Most participants understood the trial processes, such as randomisation, and information about bisphosphonates but some participants showed little understanding of certain aspects of the trial. Some participants reported difficulties in accessing dental treatment due to their dentist's perceptions of bisphosphonate treatment.
  
  
  CONCLUSIONS
  In trials of medicinal products, especially when testing for non-inferiority, participants' preferences and idiosyncrasies in relation to treatments should not be assumed. This study has shown that in a trial context, participants' views can usefully add to the main trial outcomes and they should be taken into account when prescribing in the real world.
  
  
  BACKGROUND
  ISRCTN13914201. Main ZICE MREC: 05/MRE09/57. CRUK E/04/022.
authors.affiliation: Marie Curie Palliative Care Research Centre, Wales Cancer Trials Unit, Cardiff University School of Medicine, Cardiff, UK. NelsonA9@cf.ac.uk.
authors.forename: Annmarie
authors.initials: A
authors.lastname: Nelson
authors.forename: Debbie
authors.initials: D
authors.lastname: Fenlon
authors.forename: Jenny
authors.initials: J
authors.lastname: Morris
authors.forename: Cathy
authors.initials: C
authors.lastname: Sampson
authors.forename: Emily
authors.initials: E
authors.lastname: Harrop
authors.forename: Nick
authors.initials: N
authors.lastname: Murray
authors.forename: Duncan
authors.initials: D
authors.lastname: Wheatley
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
authors.forename: Gareth
authors.initials: G
authors.lastname: Griffiths
authors.forename: Peter
authors.initials: P
authors.lastname: Barrett-Lee
mesh_terms: D000284:Administration, Oral; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000523:psychology / Q000556:secondary*; D001943:Breast Neoplasms / Q000473:pathology* / Q000523:psychology; D032882:Comprehension; D004164:Diphosphonates / Q000008:administration & dosage* / Q000009:adverse effects; D004739:England; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006297:Health Services Accessibility; D006801:Humans; D000077557:Ibandronic Acid; D007093:Imidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous; D010147:Pain Measurement; D057240:Patient Preference; D017060:Patient Satisfaction; D010361:Patients / Q000523:psychology*; D036301:Qualitative Research; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D014852:Wales; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D000077557:Ibandronic Acid